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Regulators Have Called Off the Dogs, but Concern Over Januvia Lingers - Regulators and the pharmaceutical industry have dismissed a study that noted consumer advocacy group Public Citizen referenced as “brilliantly-designed and executed.” Drs. Alexandra Butler and Peter Butler, of whom we have referenced before, undertook the study with their colleagues in concert with UCLA in California and the University of Florida.

What you need to know about acetaminophen

9/3/2013

What you need to know about acetaminophen - Acetaminophen is also the top cause of acute liver failure in the U.S. says Sidney Wolfe, M.D., a former member of the FDA’s Drug Safety and Risk Management Committee. Tylenol, in particular, is currently cited in more than 85 personal injury lawsuits for liver injuries and deaths related to its drugs.

Tort reform turns 10

9/3/2013

Tort reform turns 10 - An October 2011 report by the advocacy group Public Citizen concludes that the number of payments in 2003 was 1,093 and in 2010 it fell to 510, a drop of 53.34 percent [See chart, Number of Texas Medical-Malpractice Payments on Behalf of Physicians]. The inflation-adjusted value of those payments dropped by 70.27 percent: in 2003 it was $292.73 million and in 2010 it was $87.02 million.

U.S. Weighs Informed Consent Rules in Wake of Infant Study Controversy - The nonprofit watchdog group Public Citizen circulated OHRP’s letter to reporters, drawing widespread media attention. OHRP charged researchers with failing to provide sufficient warning to parents of the 1300 babies in the study. It said researchers should have told parents about concerns that the high-oxygen saturation group had a potentially greater risk of eye disease, while babies in the lower group might be more likely to die or suffer developmental delays. Both concerns proved true at statistically significant levels.

For Immediate Release on Tuesday, September 3 - Level playing field for union election U.S. District Judge Colleen Kollar-Kotelly ruled that challengers seeking to unseat incumbent officers of the American Postal Workers Union are entitled to use the union’s email database to send campaign literature to voters. The decision interprets a provision of the Labor-Management Reporting and Disclosure Act that provides candidates a right to distribute campaign literature at his or her own expense. Public Citizen brought the suit on behalf of three APWU candidates.

Differences on display on US informed consent rules

9/3/2013

Differences on display on US informed consent rules - After OHRP criticized the study’s consent forms in March, a string of reaction followed from the highest research echelons. They included this commentary in the New England Journal of Medicine by NIH director Francis Collins and his policy deputy, Kathy Hudson. Most of the responses defended the trial and the forms, arguing that the babies were put at no additional risk. But a vocal minority of physicians and bioethicists and the advocacy group Public Citizen have loudly disagreed. So did this Nature editorial, published last week.

Tell Congress To Get Serious About Defunding Obamacare - “After passage of major legislation, those who have networks on Capitol Hill take exceedingly lucrative jobs with the same industries subject to the legislation,” said Craig Holman, a lobbyist for Public Citizen. “It raises questions about the [bill's] integrity.”

'Big bucks' lobbying hurts political system

9/1/2013

'Big bucks' lobbying hurts political system - Public Citizen, a watchdog group, recommends that the cooling off period be extended to two years -- I would say five -- and that the supervision of other lobbyists be prohibited. The group would also revoke the special privileges that former members are afforded, for example, access to the House and Senate floor and to members-only gymnasiums and restaurants

NIH trial weathers censure: Organization calls trial’s consent forms inadequate - Michael Carome, the director of Public Citizen’s Health Research Group, said the group does not believe TOP informs parents of the full risks involved should their children be assigned to the low-hemoglobin group. “We believe that the consent forms are not adequately informing the parents of the premature babies being enrolled in the research about many important facets of the research,” he said. “In order for human research to be ethical, one of the fundamental things it has to include is adequate informed — and I put emphasis on the informed — consent.”

Finding common ground on SUPPORT: Reflections from DHHS public meeting

8/4/2013

Finding common ground on SUPPORT: Reflections from DHHS public meeting - While some, including representatives of Public Citizen and the Alliance for Human Research Protection, continue to argue that SUPPORT was an unethical study to conduct, the majority of presenters agreed that SUPPORT, and studies like it, are worth doing and, more generally, that we collectively should be committed to addressing the alarming fact that much of what is done as a matter of routine clinical care is not supported by good evidence.

Good medicine or TMI? What happens if you screen all of a baby’s genes?

8/4/2013

Good medicine or TMI? What happens if you screen all of a baby’s genes? - At least one consumer advocacy group, Public Citizen, expressed some concerns. “It’s actually proceeding to do genomic sequencing in newborns while at the same time trying to determine what are the ethical implications of that. Maybe they are getting ahead of themselves,” said the group’s Dr. Michael Carome.

ObamaCare’s Architects Reap Windfall as Washington Lobbyists - “After passage of major legislation, those who have networks on Capitol Hill take exceedingly lucrative jobs with the same industries subject to the legislation,” said Craig Holman, a lobbyist for Public Citizen. “It raises questions about the [bill's] integrity.”

Medical-Ethics Dilemmas Pondered In Week’s News

8/4/2013

Medical-Ethics Dilemmas Pondered In Week’s News - The consumer group Public Citizen is alleging that a major study funded by the U.S. government is ethically flawed, according to a report from National Public Radio. The study randomly assigned premature infants to a group that receives transfusions when their anemia is mild and to another group that will receive treatment after the condition becomes severe. It is not known at present which approach is more effective in reducing deaths and brain damage. Public Citizen claims that parents are not being adequately informed of the risks of such treatments as compared to usual care, where the group says treatments are highly customized to individual situations.

New Report Details Keystone XL's Significant Climate Impact Using Data from Industry - Washington, DC – A group of environmental advocates delivered a report on the climate implications of the Keystone XL tar sands pipeline to the President on August 29, giving him all of the information he needs to reject the tar sands pipeline based on its significant impact on carbon pollution… The report was release by: Sierra Club, 350.org, Bold Nebraska, National Wildlife Federation, OiL Change International, Friends of the Earth, Credo, Center for Biological Diversity, American Sustainability Business Council, Environment America, Environment Maine, Green America, Public Citizen, Labor Network for Sustainability.

Recalls Continue, but Compounding Legislation Stalls

8/4/2013

Recalls Continue, but Compounding Legislation Stalls - As the compounding legislation awaited further developments, Public Citizen, the Washington, D.C.-based public health advocacy group, sought to keep safety and regulatory oversight top-of-mind by issuing a critique of how the FDA handled the Specialty Compounding recall. At press time, the group charged that the FDA knew of potentially unsafe drug production practices at the Texas compounder as early as March 2013, when the agency found manufacturing issues during an inspection of the facility. And yet Specialty Compounding didn’t issue its voluntary product recall until Aug. 9, Public Citizen pointed out.

Petition Seeks Boxed Plavix Warning

8/4/2013

Petition Seeks Boxed Plavix Warning - The group Public Citizen says regulators should warn doctors and patients that taking the widely-prescribed drug for more than a year after receiving a drug-coated stent can lead to fatal bleeding.

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Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

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